Status:
COMPLETED
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Migraine
Migraine;Menstrual
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
Eligibility Criteria
Inclusion
- Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
- Will maintain their implant during the study without modifications.
Exclusion
- Women who are taking any medications or supplements known to be
- Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
- are not willing to abstain from any of these medications or supplements during the entire course of the study.
- Women with liver disease (i.e. hepatitis, fatty liver disease), and
- Women with abnormal liver or renal function, or
- Women with abnormal electrolytes on their screening blood work.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03335163
Start Date
March 15 2018
End Date
April 22 2021
Last Update
July 13 2022
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045